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Not yet recruiting NCT06841900

Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

— Observational Cochlear Impant Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cochlear Implantation.
Who it may be relevant to
Registry conditions: Cochlear Impant Children. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Belgium, Germany, Poland, Saudi Arabia +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients: a Multi-center Prospective Follow-up Cohort Study

Overview

The aim of this study is to implement the International Classification of Functioning, disability and health (ICF) in paediatric Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss in a multicenter prospective study to evaluate audiological rehabilitation after cochlear implantation. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified. Outcome measures include four questionnaires and three standard audiological examinations. Subjects will be assessed up to 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor.

Interventions

  • Device Cochlear Implantation
    Standard cochlear implantation

Primary outcome measures

  • Change in LittlEARS® Auditory Questionnaire (LEAQ) [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]
  • Change in Speech, Spatial and Qualities of Hearing Scale for Parents (SSQ-P) [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]
  • Change in Speech Intelligibility Rating (SIR) [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]
  • Parent's Evaluation of Aural/Oral Performance of Children (PEACH) [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]
  • Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]
  • Auditory Brainstem Response (ABR) Audiometry [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]
  • Ling Sounds (detection/discrimination) [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]
Secondary outcome measures (1)
  • Subject Demographics [Time frame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor]

Eligibility criteria

Inclusion criteria

General

  • Children aged < 18 years with prelingual bilateral severe-to-profound HL
  • Signed and dated informed consent, informed permission and/or minor's assent.
  • Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
  • Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.

Audiological

  • Completion of hearing assessment battery showing suitability of the CI candidates.
  • Compliance with cochlear implant candidate selection criteria of the implanting centre.
  • First cochlear implantation Medical
  • Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).

Exclusion criteria

General

  • Re-implantation of the cochlear implant
  • No motivation to participate in the study and/or unreasonable expectations. Medical
  • Presence of contra-indications for surgery in general and cochlear implantation in particular.
  • Presence of central auditory lesions.
  • Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation
  • Compressed
  • Split
  • Any type of custom made electrodes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 1 center
  • Fiona Stanley Fremantle Hospital Group — Perth
Belgium · 1 center
  • University Hospital Antwerp — Edegem
Germany · 1 center
  • University Clinic of Würzburg — Würzburg
Poland · 1 center
  • World Hearing Centre — Warsaw
Saudi Arabia · 1 center
  • King Abdullah Ear Specialist Center (KAESC) — Riyadh
Spain · 1 center
  • Hospital La Paz — Madrid

Identifiers

NCT: NCT06841900 · ICF in Paediatric CI users

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗